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Device | PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH |
Generic Name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
Applicant | PROSTALUND AB SCHEELEVAGEN 17 SE-223 63 LUND SE-22-223 |
PMA Number | P010055 |
Date Received | 09/10/2001 |
Decision Date | 12/23/2002 |
Product Code |
MEQ |
Docket Number | 03M-0189 |
Notice Date | 05/09/2003 |
Advisory Committee |
Gastroenterology/Urology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE PROSTALUND CORETHERM MICROWAVE THERMOTHERAPY SYSTEM. THE PROSTALUND CORETHERM IS A NON-SURGICAL, MINIMALLY INVASIVE DEVICE INTENDED TO RELIEVE SYMPTOMS ASSOCIATED WITH SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) BYE PROSTALUND FEEDBACK TREATMENT (PLFT), AND IS INDICATED FOR MEN WITH PROSTATE SIZE OF 30 TO 100G AND PROSTATIC URETHRA LENGTH >= 35 MM. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S009 S011 |